India approves its first Dengue Vaccine QDENGA after DCGI clearance

India has approved its first dengue vaccine, with the Drug Controller General of India (DCGI) granting market authorisation to vaccine QDENGA, developed by Takeda Biopharmaceuticals India. The approval marks a major step in India’s fight against dengue, a mosquito-borne disease that affects millions of people every year.
Qdenga® is a live, attenuated tetravalent dengue vaccine developed using recombinant DNA technology.
The vaccine is produced in Vero cells, with genes encoding serotype-specific surface proteins engineered into a dengue virus type-2 backbone.
The product contains genetically modified organisms (GMOs). It is supplied as a freeze-dried powder for reconstitution and is administered as a subcutaneous injection.
The vaccine is indicated for the prevention of dengue disease in individuals 4 to 60 years of age. The recommended immunisation schedule consists of two doses of 0.5 ml each, administered at an interval of three months (0 and 3 months).
Unlike some dengue vaccines, QDENGA does not require pre-vaccination screening, allowing eligible individuals to receive the vaccine without first being tested for past dengue infection.
The approval comes as India continues to shoulder one of the world’s highest dengue burdens, with cases increasing sharply over the past two decades due to urbanisation, climate change, changing mosquito habitats and population growth.
QDENGA is a live-attenuated tetravalent vaccine, meaning it is designed to protect against all four dengue virus serotypes (DENV-1, DENV-2, DENV-3 and DENV-4). The vaccine has already been approved in more than 40 countries, including the European Union, the United Kingdom, Brazil, Indonesia and Argentina.
India now joins that list at a time when dengue is emerging as one of the country’s biggest seasonal public health threats. The Company said, QDENGA has also received WHO prequalification, confirming that it meets international standards for quality, safety and effectiveness.
This also makes the vaccine eligible for procurement by global agencies such as UNICEF and the Pan American Health Organization (PAHO).
Dengue is a mosquito-borne viral disease that poses a significant global public health threat, with prevalence in over 125 countries. India accounts for nearly one-third of the global dengue burden.